Abbott warned by FDA over Abbokinase

The US Food and Drug Administration has informed Abbott Laboratoriesthat it has additional concerns relating to "serious deficiencies" in the manufacture of its thrombolytic Abbokinase (urokinase). Until these issues are resolved, says the FDA, "further distribution of Abbokinase would violate federal laws."

The concerns relate to contamination with micro-organisms such as neovirus and mycoplasma. While the company assures the FDA that none of these batches were distributed, the agency says that these findings and "Abbott's inability to locate the source of the problem" have raised further concerns about the entire manufacturing process. Abbokinase is derived from cultures of human kidney cells taken from newborns who have died of natural causes.

Manufacturing problems were first highlighted in 1998, and earlier this year the agency advised physicians to prescribe Abbokinase as a last-resort therapy because of the potential risk of spreading infectious disease (Marketletter February 8). However, since the "Dear Doctor" letter was distributed, additional inadequacies in the screening process for mothers and donors of the human kidney cells have been unearthed, notes the FDA.